Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Engineer-Upstream/Downstream

What you will do

Let’s do this. Let’s change the world. In this dynamic role you will join the Drug Substance Technology Engineering team supporting Amgen Thousand Oaks (ATO) Drug Substance Manufacturing facilities. Responsibilities include:

• Transfer cell culture/purification drug substance processes and perform process improvements from the laboratory into the manufacturing facility and between manufacturing sites
• Provide process validation support for late stage commercial processes
• Provide on-the-floor technical support for successful scale-up and transfer of process technology, and for clinical or commercial manufacturing operations
• Provide routine process monitoring and troubleshooting
• Perform data trending and statistical process analysis
• Provide technical contributions for process related deviations (NCs), CAPAs and change controls
• Identify and support process related operational excellence opportunities
• Represent process development and collaborate with other functions such as Manufacturing, Quality, and Regulatory

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Engineer professional we seek is a collaborative partner with these qualifications.

Basic Qualifications:

• Master’s degree OR
• Bachelor’s degree and 2 years of Process Development experience OR
• Associate’s degree and 6 years of Process Development experience OR
• High school diploma / GED and 8 years of Process Development experience

Preferred Qualifications:

• Master’s degree in Chemical/Biochemical Engineering or related subject area
• 3 + years of experience in Process Engineering related to biochemical engineering and/or protein biochemistry, scale-up principles and manufacturing of biologics (cGMP)
• Upstream and/or Downstream process knowledge and hands on cell culture and/or purification pilot/clinical/commercial experience with regard to the manufacture of a biological drug substance
• Experience working in/supporting a commercial cGMP manufacturing facility
• A firm understanding of cell culture process and related equipment; scale-up from bench to commercial scale, mass oxygen transfer capabilities, metabolism profiling, influence of raw material attributes and impact of process deviations to growth and quality attributes
• Knowledge of aseptic processing/techniques, harvest and clarification processes used in mammalian cell culture processes AND/OR a good understanding of purification process and associated equipment; chromatography, ultrafiltration, normal flow filtration, virus inactivation and virus filtration operations
• Process development (PD) experience supporting cGMP manufacturing at large scale
• Strong capability in scientific/engineering/laboratory analysis, troubleshooting and ability to apply sophisticated problem resolution abilities
• Ability to develop and follow detailed protocols
• Independently motivated with ability to multi-task and work in teams
• Excellent written and verbal communication with experience with technical writing and presentations

Some of the vast rewards of working here

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

• Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
• A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor